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T. R. Friberg, LEVEL Study Group; Evaluation of Efficacy and Safety in Maintaining Visual Acuity with Sequential Treatment of Neovascular AMD: The LEVEL Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4568.
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To explore the safety and efficacy of pegaptanib as a maintenance therapy in patients with neovascular age-related macular degeneration (NV-AMD) who have had improvement of their disease after recent treatment.
In a phase 4, multicenter, open-label study, we enrolled subjects ≥50 years of age with subfoveal NV-AMD who had received ≥1 and ≤3 NV-AMD treatments. Prior therapy had to have been given 30 to 120 days before entry and had to have resulted in investigator determined clinical/anatomical improvement of NV-AMD. Anatomical improvement was defined as presenting at baseline with a center point retinal thickness ≤275 microns or a thinning of ≥100 microns on OCT. Other key inclusion/exclusion criteria were visual acuity (VA) of 20/20 to 20/400, lesions of all subtypes up to 12 disc areas in size, and no subfoveal atrophy or scarring. Subjects received intravitreal pegaptanib, 0.3 mg injected every 6 weeks for 48 weeks. Booster treatment other than pegaptanib could be added at the investigator’s discretion for deteriorating NV-AMD. VA was measured at baseline and pre-injection at each treatment visit. At baseline and at each treatment visit, tonometry and an ophthalmic exam were performed, and information concerning safety and adverse events was recorded. Fundus photography and fluorescein angiography (FA) were obtained at baseline and week 54; OCT was conducted at baseline and weeks 12, 24, 36, and 54. Study endpoints at week 54 were the proportion of subjects maintaining or gaining VA from baseline; proportion of subjects maintaining or gaining VA at week 54 compared to pre-enrollment (initiation of prior treatment) vision; mean change in VA from baseline over time; proportion of subjects losing ≤3 lines of VA from baseline; and anatomical outcomes on FA and OCT.
In all, the study is designed to assess 1000 subjects at 100 US sites. To date 151 subjects have been enrolled (89 women and 62 men). Results of an inclusive interim analysis will be presented.
The LEVEL trial has potentially important therapeutic and safety implications in the management of neovascular AMD.
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